THU0164 PERFUSE: A FRENCH PROSPECTIVE/RETROSPECTIVE NON-INTERVENTIONAL COHORT STUDY OF INFLIXIMAB-NAIIVE AND TRANSITIONED PATIENTS RECEIVING INFLIXIMAB BIOSIMILAR SB2; AN INTERIM ANALYSIS
Authors: B. Fautrel, Y. Bouhnik, G. Desjeux, A. Brigui, U. Freudensprung, J. Addison
Journal: Annals of the Rheumatic Diseases (2020)

Background: SB2 is approved in the EU as an infliximab (IFX) biosimilar, having demonstrated bioequivalence and similar efficacy, safety and immunogenicity as the reference. There is limited real-world evidence published on persistence, effectiveness or safety of SB2, in IFX-naiive patients or those transitioning from originator or another IFX biosimilar. Objectives: PERFUSE is an ongoing non-interventional study of 1374 patients (500 with rheumatology diagnoses, 874 with gastroenterology diagnoses) receiving SB2 as routine therapy, with objectives to describe clinical characteristics, effectiveness, treatment persistence and safety in patients initiating SB2 and followed for 24 months at 21 specialist sites across France. Methods: Adult patients eligible for inclusion in the rheumatology study cohorts have a diagnosis of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) and initiated SB2 in routine clinical practice after September 2017, either as their first IFX or transitioning from treatment with IFX reference or another IFX biosimilar. Data are captured from patients’ clinic records. Outcome measures include persistence on SB2, clinical characteristics at baseline (time of SB2 initiation), disease scores and Serious Adverse Events (SAEs). Results: This 12-month interim analysis includes 500 patients (99 with RA, 62 with PsA and 339 with AS). M12 persistence on SB2 for IFX-naiive and transitioned patients combined was 73.8% (95% CI 61.5, 84.0), 76.2 % (95% CI 60.5, 87.9) and 71.5 % (95% CI 65.6, 76.9) in RA, PsA and AS respectively. In patients with prior IFX, no clinically meaningful difference in disease activity score from baseline to M12 was observed (Table 1). Low sample size precluded interpretation of disease score in the IFX-naiive cohort (not shown in Table 1). All 7 reported SAEs are unrelated to SB2: prostate and breast carcinoma in the RA cohort; alcohol poisoning, nephrostomy, epistaxis, cutaneous lesion and malleolar fracture in the AS cohort. Table 1 RA (N=99 ) PsA (N=62 ) AS (N=339 ) Age (mean, SD) 56.5 (13.8) 52.1 (12.9) 47.7 (12.5) Disease duration (mean, SD) 16.0 (9.4) 10.9 (10.7) 14.4 (11.8) Female (n) (%) 77 (77.8) 21 (33.9) 107 (31.6) IFX-Naiive (n) (%) 22 (22.2) 14 (22.6) 80 (23.6) Transitioned from Reference (n) (%) 37 (37.4) 24 (38.7) 111 (32.7) Transitioned from Biosimilar (n) (%) 40 (40.4) 24 (38.7) 148 (43.5) SB2 Persistence at M12: n on SB2 at M12 (total n at M12), % (95% CI* ) IFX-Naiive 5 (9) 55.6% (21.2, 86.3) 3 (7) 42.9% (9.9, 81.6) 21 (48) 43.8% (29.5, 58.8) Transitioned from Reference 14 (22) 63.6% (40.7, 82.8) 15 (17) 88.2% (63.6, 98.5) 68 (87) 78.2% (68.0, 86.3) Transitioned from Biosimilar 29 (34) 85.3% (68.9, 95.0) 14 (18) 77.8% (52.4, 93.6) 99 (128) 77.3% (69.1, 84.3) Disease score in switched patients n DAS-28 mean (95% CI ) n DAS-28 mean (95% CI ) n BASDAI mean (95% CI ) Baseline 47 2.5 (2.2, 2.8) 19 2.2 (1.5, 2.8) 202 3.0 (2.7, 3.3) M12 36 2.7 (2.3, 3.1) 14 2.0 (1.4, 2.6) 136 2.8 (2.5, 3.2) Change from baseline at M12 26 0.5 (-0.1, 0.9) 9 0.0 (-0.7, 0.6) 125 0.1 (-0.2, 0.5) * Clopper Pearson Conclusion: This interim analysis indicates that patients with RA, AS or PsA can be successfully transitioned from originator or biosimilar IFX to SB2, without loss of disease control and with no safety concerns. The majority of transitioned patients continued SB2 treatment at M12 post-initiation. The PERFUSE study will provide ongoing, pertinent information about outcomes in these populations, helping to inform evidence-based treatment decisions. Disclosure of Interests: Bruno Fautrel Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Consultant of: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Medac MSD France, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi Aventis, SOBI and UCB, Yoram Bouhnik Consultant of: AbbVie, Biogaran, Biogen, Boehringer Ingelheim, CTMA, Ferring, Gilead, Hospira, ICON, Inception IBD, Janssen, Lilly, Mayoly Spindler, Merck, Merck Sharp &amp; Dohme, Norgine, Pfizer, Robarts Clinical Trials, Roche, Sanofi, Shire, Takeda, UCB, Vifor Pharma, Guillaume Desjeux: None declared, Amira Brigui Shareholder of: Biogen France SAS, Employee of: Biogen France SAS, Ulrich Freudensprung Shareholder of: Biogen International GmbH, Employee of: Biogen International GmbH, Janet Addison Shareholder of: Biogen Idec, Employee of: Biogen Idec